CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS

Plain-language summary

This study evaluates CMV/HIV-CAR T cells, a type of immune-cell therapy, as an immunotherapy for people with HIV/AIDS. It enrolls adults aged 18 and older with HIV-1 infection who have been on stable antiretroviral therapy for at least 48 weeks with an undetectable virus level. The study is in Early Phase 1 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Early Phase 1

Status

Recruiting

Sponsor

City of Hope Medical Center

Intervention

CMV/HIV-CAR T Cells

Start date

12/19/2024

Estimated completion

12/11/2026

Countries

United States

Related genes

Locations

• Duarte, United States
• San Diego, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Participant must be ≥ 18 years of age at the time of screening;
* Karnofsky Performance Status (KPS) ≥ 70;
* Documented HIV-1 infection anytime prior to study entry.;
* On stable ART with undetectable HIV-1 RNA (i.e \< 20 copies /mL) for at least 48 weeks prior to screening (2 plasma HIV-1 RNA blips 25-200 copies/mL are allowable);
* CD4+ cell count ≥ 450 cells/μL;
* Adequate organ function;
* Willingness to interrupt ART regimen for 4 days prior to leukapheresis;
* Not pregnant or breastfeeding.

Exclusion Criteria:

* Concurrent illness or comorbid condition;
* History of resistance to two or more classes of antiretroviral drugs;
* History of prior receipt of an experimental HIV-1, immunotherapeutic agent, or gene therapy product.